Can organisations introduce automation and remain compliant?

Reducing time to market is increasingly important for all businesses as they seek to lower costs and increase revenues, and the pharmaceutical industry is no exception. Pharma and biotech organisations need to create breakthrough medicines quickly, while simultaneously juggling sensitive data and complying with stringent regulations. To help, some organisations are turning to process improvements, such as laboratory automation, to optimise work and to obtain efficiency gains — but can organisations introduce automation and remain compliant? In this online exclusive, Stuart Ward, head of Business Analysis at R&D software provider, IDBS, tells us more…

Automation in the lab can range from robotics and equipment, such as automated plate readers, through to electronic data management systems, like ELNs and LIMS, which can record and analyse any data that is obtained. All automated systems provide some advantages on their own, but the real benefits come when multiple systems are integrated together. Using end-to-end automation that reduces human or manual input, from obtaining data through to the actual analysis of data, enables organisations to introduce easily repeatable processes and reduce the risk of transcription errors.

These aspects are critical when data is provided to regulatory authorities and organisations need to prove that the data is complete and also a true record of what occurred. In general, when humans interact with regulated data, these ‘data change events’ need to be witnessed (the ‘four eyes’ principle), whereas automated systems — with the appropriate controls in place — can streamline this need by automatically reporting any alteration for easy review.

What to consider before automating

Before automating your lab, it is essential to implement an appropriate automation strategy and conduct rigorous testing, so you can be certain that data is being passed between systems correctly and confident that working fail safes are in place to prevent any data loss or transfer errors. This ensures that the behaviour of the automation process is fully understood and meets the business’ needs. In addition, the information obtained during the testing stage can be provided to regulatory agencies to give them confidence that the system is operating as required and in a consistent manner.

The use of automation has opened the discussion around security of the process and the data obtained. Traditionally, manual and paper-based processes tend to be organised and controlled by a single individual, whereas automated systems can allow more user interaction — meaning more questions are likely to be asked around the security of the information captured and stored.

To demonstrate compliance, organisations need to prove to regulators that neither the process or data have been tampered with, so appropriate procedures need to be put in place. These can range from having suitable infrastructure protection, such as corporate firewalls and building access control systems, through to appropriate software controls, such as individual authentication, granular authentication mechanisms and audit trails to record what changes to the data occurred and who made the changes.

Facilitate electronic submission and compliance

For the majority of cases, the security controls in place for laboratory automation — both for equipment and software — are accepted by the various regulatory authorities and are usually seen as an advantage, because the amount of information available is far greater than what can be obtained from a comparable paper-based process. In addition, the use of electronic systems can also help facilitate the electronic submission of data to the regulatory agencies, reducing the likelihood of transcription errors and submission of incomplete data, allowing better and faster decisions to be made around whether a drug is suitable for its designed use.

There are further security challenges to overcome too, particularly when processes are moved outside of the organisation — as seen through the increased use of CROs and CMOs within the life science domain. When working with external companies, how can you be sure that data is being shared securely and reliably? Many organisations are turning to collaboration software solutions that can facilitate this sharing of data securely and, more importantly, integrate to provide end-to-end automation — minimising the need for manual data transfer and reducing the risk of introducing errors in the data.

Removing human error from your processes

Laboratory automation can provide significant benefits to an organisation from efficiency gains to meeting regulatory compliance. To ensure that the deployment is successful, organisations need to fully understand the process being automated and ensure that appropriate safeguards are in place to prevent data loss or alteration. As integration is key, it is important that the software solutions deployed have a standard mechanism to pass data between systems. This will ensure that the movement of data can be kept transparent through the whole automated process and it will be easier to ensure that it’s working, according to the business needs, all while removing the need for error-prone human interventions.

The question is not (with the increasing pressures of reduced time to market only squeezing organisations further) “will they automate”, but rather “when?”